Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina

This study aims to evaluate the effectiveness of a Cloak Shape sham Pediatric Tuina device which can be applied in randomized controlled trials for Pediatric Tuina research.

Study Overview

• Status: Completed
• Conditions: Child
• Intervention / Treatment: Device: Cloak Shape Device for Genuine Tuina; Device: Cloak Shape Device for Sham Tuina

Detailed Description

Chinese pediatric Tuina has been practiced as an option for health promotion, including disease prevention and treatment, more than one thousand years ago (652 AD). Many of the acupoints adopted in Chinese pediatric Tuina are located on children's fingers, hands and arms, which are unique if it is compared with those for adult tuina. The manipulation is found to be easily accepted by children, as the strength of tuina is gentle and soft. No severe adverse reaction in regards of Chinese pediatric Tuina was reported, the mild adverse reaction such as skin abrasion can be completely avoided with correct operating instructions. However, it is still lack of high quality RCTs (Randomized Controlled Trials) to evaluate its efficacy. The main obstacle is the difficulty to conduct a valid sham Tuina comparison group. In order to solve this problem, the investigators designed a device for sham Tuina, with a Cloak Shaped cover which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes. The whole manipulation process will be invisible under the cover.The investigators aim to detect whether it is effective as a sham device for pediatric Tuina researches.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China, 523080
      • Dongguan Kanghua Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children with disease in Pediatric Outpatient Department of Kanghua Hospital
2. Children aged 0-6 years.
3. Guardian and child can be cooperative over the study period.
4. Guardian signed the informed consent.
5. Children have no attendance in other studies simultaneously.

Exclusion Criteria:

1. Child with one or more PT experiences on arms, abdomen or back.
2. Child with a previous history of convulsion.
3. Child with any of the following conditions on the area to be manipulated: phlebitis, open wound, fracture and tissue damage.
4. Child combined with any of following conditions: disorders of consciousness, seizures or twitching, shock, varicella, hand-foot-mouth disease, encephalitis B, and etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Genuine Tuina; Participants will receive genuine tuina manipulated on their skin in addition to the conventional therapy given by the doctors. The whole process of the Tuina, which may last for 15 minutes, should be completed under the Cloak Shape device. After that the parents and the observers may be required to fill out corresponding questionnaires. The outcomes assessors will ask the child the sense perception of the manipulation via a questionnaire if he is equal or older than 3 years old.	Device: Cloak Shape Device for Genuine Tuina; The Cloak Shape Device for Genuine Tuina is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a genuine Tuina will be manipulated.
SHAM_COMPARATOR: Sham Tuina; Except for the conventional therapy given by doctors, participants in this group will receive sham Tuina. A cloak shape device will be adopted, while inside the cover the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead of childrens' hand or childrens' body. The acupoints and the manipulation time are the same as real Tuina group. Same questionnaires as those adopted in real Tuina group are also required to be completed.	Device: Cloak Shape Device for Sham Tuina; The Cloak Shape Device for Sham Tuina is exactly the same as the real one, which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a sham Tuina will be manipulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations	The accuracy judgement rate was calculated from the original data as below and was used as the primary outcome in the study.	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Observers' Evaluations	The accuracy judgement rate was calculated from the original data as below and was used as the primary outcome in the study.	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Rating Scale (VRS) of Parent's Attitude Towards Pediatric Tuina	We adopt the VRS-4 to indicate diferent confident intensities towards pediatric Tuina from the perspective of parents as follow: not confident, somewhat confident, confident ,very confident.	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Verbal Rating Scale (VRS) of Children's (≥3 Years Old) Perception of Pediatric Tuina	We adopt the VRS-5 to indicate diferent discomfort intensities towards pediatric Tuina from the perspective of children equal or larger than 3 years old during and after the Tuina as follow: no discomfort; some discomfort; discomfort; very uncomfortable ; uncertain.	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
VRS of Parent's Attitude Towards Pediatric Tuina From the Observers' Perspectives	We adopt the VRS-4 to indicate diferent trust intensities of the parents towards pediatric Tuina from the perspective of observers' perspectives as follow: Not confident, somewhat confident, confident, very confident.	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.
Compliance of Guardians and Children for Three Continuous PT Therapies	We adopt the VRS-4 to indicate diferent compliance intensities to follow 3 days continuous Tuina therapies as follow:improbable, somewhat improbable, probable, very probable.	The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborators: Dongguan Kanghua Hospital
• Investigators: Principal Investigator: Darong Wu, MD,PhD, Guangzhou University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2018
• Primary Completion (ACTUAL): August 15, 2018
• Study Completion (ACTUAL): August 15, 2018

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (ACTUAL): March 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Massage therapy; Pediatric Tuina; Sham Tuina; Sham massage; Sham device
• Other Study ID Numbers: Z2017-212-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No